Saturday, January 16th, 2021

HHS, DoD order 100 million doses of Moderna’s still-in-trial COVID-19 vaccine

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Under a new agreement reached with Moderna, Inc., the U.S. Departments of Health and Human Services (HHS) and Defense (DoD) have ordered 100 million doses of the mRNA-1273 vaccine, a candidate for use against COVID-19.

That vaccine was co-developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID). A phase 3 clinical trial, which began July 27, is still ongoing, with support from the Biomedical Advanced Research and Development Authority (BARDA).

Under the new agreement, Moderna will manufacture the vaccine doses in tandem with ongoing clinical trials, increasing the likelihood of the federal Operation Warp Speed goal of gaining a vaccine by the end of the year. The federal government would own these doses outright and, if the U.S. Food and Drug Administration (FDA) were to authorize mRNA-1273 for use, the vaccine doses would be distributed as part of a COVID-19 vaccination campaign.

“In creating a vaccine portfolio for Operation Warp Speed, the Trump Administration is increasing the likelihood that the United States will have at least one safe, effective vaccine by 2021,” HHS Secretary Alex Azar said. “Today’s investment represents the next step in supporting this vaccine candidate all the way from early development by Moderna and the National Institutes of Health, through clinical trials, and now large-scale manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”

Part of the agreement also stipulates that the government can acquire up to 400 million more doses of the vaccine.

Fill-finish manufacturing will be undertaken at U.S.-based facilities, to guarantee doses are packaged and ready to ship upon successful completion of clinical trials and FDA authorization. During any vaccination campaign, these vaccines would be provided to U.S. citizens free of charge, though healthcare professionals could charge for the cost of administering them.

BARDA, in collaboration with DoD, has provided up to approximately $1.5 billion to manufacture and deliver the vaccine to government-designated locations throughout the United States.